Hygienic Standard for Enterprises Producing Gelatin as Food Additive
Shanghai Nena Environmental Technology Co., Ltd. 2008-10-27 14:04:54
Chapter One General Provisions
Article 1 This Hygienic Standard is formulated to strengthen the sanitary supervision and management of enterprises producing gelatin as food additive, ensure the hygiene and safety of products, in accordance with the relevant provisions of the "Food Hygiene Law of the People's Republic of China" and the "Hygiene Management Measures for Food Additives".
Article 2 This Standard specifies the requirements for site selection, design and facilities, production process hygiene, hygiene quality inspection, storage and transportation hygiene, and personal hygiene and health for enterprises producing gelatin as food additive.
Article 3 Enterprises engaged in the production of gelatin as food additive must comply with this Standard. The person in charge of the production enterprise is the first responsible person for the hygiene and safety of food additives, and must clearly define and fulfill the responsibility to ensure the safety of food additives.
Article 4 Health administrative departments of people's governments at all levels supervise the implementation of this Standard.
Chapter Two Site Selection, Design, and Implementation Hygiene Requirements
Article 5 For newly built, renovated, or expanded enterprises producing gelatin as food additive, the site selection, design, and construction of the production premises, in addition to complying with the relevant national regulations on project management, should also meet the requirements of this Standard. Approval from the health administrative department of the province, autonomous region, or municipality directly under the Central Government is required, along with final acceptance inspections.
Article 6 Enterprises producing gelatin as food additive should be located in areas with dry terrain, abundant water sources, convenient transportation, and not affecting the lives and safety of surrounding residents. Factory roads should be hardened to prevent dust and water accumulation. The surrounding environment of the factory area should be greened, and within 25 meters there should be no dust, harmful gases, radioactive substances, or other diffusive pollution sources.
Article 7 Corresponding hygiene safety measures should be in place during the production process. Production sites that may produce harmful gases, dust, noise, and sewage should be separately set up, with appropriate health protection distances and measures from residential areas. Facilities for detoxification, dust prevention, noise reduction, and sewage treatment should be installed to meet national requirements.
Article 8 Buildings, equipment layout, and production processes should be reasonably coordinated to ensure the continuity of production and prevent cross-contamination. The factory area should be reasonably laid out, divided into production and living zones. The production zone should be further divided according to hygiene requirements into general operation areas, quasi-clean areas, and clean areas. General operation areas include raw material warehouses, raw material processing (swelling, acidification, washing), and finished product warehouses; quasi-clean areas include extraction, filtration, and steam concentration processes; clean areas include gel solution freezing, drying, crushing, semi-finished product storage, mixing, and packaging processes.
Article 9 The setting up of power, heating, air conditioning rooms, water supply and drainage systems, wastewater and waste residue treatment systems, and other auxiliary buildings and facilities should not affect the hygiene of the production site and should not pollute the surrounding environment.
Article 10 There should be production space commensurate with the scale of production, with a minimum clear height of not less than 3 meters and a usable area of not less than 1500 square meters. The passages in the production workshop should be spacious, designed without obstacles, ensuring transportation and hygiene safety protection.
Article 11 The floor of the production workshop should be flat, slip-resistant, wear-resistant, corrosion-resistant, non-permeable, and easy to clean. Work areas requiring cleaning should have a slope of 1°-2°, with floor drains at the lowest point, preventing water accumulation.
Article 12 The walls and roof of the production workshop should be made of light-colored, moisture-proof, anti-corrosive, non-toxic, non-detachable materials. Doors and windows should be made of rust-proof, easily washable sealed frame structure materials.
Article 13 The production workshop should have good ventilation. When using natural ventilation, the ratio of ventilation area to floor area should not be less than 1:16; when using mechanical ventilation, the air change rate should be no less than three times per hour.
Article 14 The production workshop should have good natural lighting and artificial illumination. The mixed illumination of the work surface in the inspection area should not be less than 540LX, in the processing area not less than 220LX, and in other areas generally not less than 100LX.
Article 15 Equipment, tools, pipelines, and containers used in the production of gelatin as food additive must meet the corresponding hygiene requirements, made of non-toxic, odorless, corrosion-resistant, non-permeable, and non-deformable materials.
Article 16 The quality and quantity of production water should meet the process requirements, and the water quality should comply with the hygiene standards for drinking water.
Article 17 Buildings and various facilities should be equipped with effective dustproof, rat-proof, and mosquito-proof facilities based on process requirements and product characteristics.
Article 18 In places where strong acids, strong alkalis, and other corrosive chemicals are used or stored, there should be clear warning signs and emergency handling facilities.
Article 19 At the personnel entrance of the production area in the gelatin production workshop, a changing room should be set up with corresponding changing facilities, equipped with running water handwashing and hand disinfection facilities. Toilets should be located outside the workshop and must be flush toilets.
Article 20 Air purification workshops should have air intake outlets away from exhaust outlets. Intake outlets should be more than 2.0 meters above the ground, and there should be no pollution sources nearby.
Article 21 Installation of production equipment, electrical pipelines, water pipes, and steam pipes should prevent water droplets and condensation from contaminating products and containers. Enterprises are encouraged to automate, pipeline, and close their production processes.
Chapter Three Hygiene Requirements for the Production Process
Article 22 Enterprises producing gelatin as food additive should establish a sound hygiene safety assurance system, formulate operating procedures and hygiene management systems for each process, and appoint hygiene managers to strictly follow these procedures and systems.
Article 23 Enterprises producing gelatin as food additive should establish a sound inspection system, set up hygiene quality inspection laboratories adapted to product characteristics, and equip them with corresponding inspection instruments and equipment.
Article 24 Raw materials purchased must meet relevant standards and regulations, with inspection and quarantine certificates provided by suppliers. Imported raw materials should have inspection and quarantine certificates issued by port food hygiene supervision and inspection institutions. Sources of raw materials: (1) Fresh cattle, pig, sheep, and other livestock skins and bones from slaughterhouses, meat factories, canneries, and vegetable markets; (2) Untanned raw skins such as hair-edge leather, second-layer leather, and triple-clean leather from leather factories; Use of tanned blue alum leather waste from leather factories is prohibited. (3) Clean bone granules processed by bone particle processing plants and naturally air-dried bone materials directly acquired.
Article 25 Hygiene requirements for each step in the production process of gelatin as food additive:
1. Pre-treatment of raw materials, including washing, acidification, alkali swelling, and neutralization, requires reaction vessels to be kept clean and free of dirt and debris.
2. When determining the endpoint of neutralization and water washing for skin and bone materials, strict hygiene quality indicators must be followed to control the residual amount of processing aids such as acids, alkalis, and lime in the skin and bone materials, meeting the control requirements for gelatin as food additive. Specifically: calcium ion (Ca+) content should be below 6000 mg/kg; chloride ion (Cl-) content should be below 3000 mg/kg. After passing the intermediate control personnel's inspection, the materials enter the extraction pot for gel extraction.
3. Extracted gel solutions passing through filtration and concentration equipment require containers, pipelines, and valves to be kept clean and hygienic, with necessary cleaning and disinfection. No non-food-grade preservatives or chemicals should be added to the gel solution.
4. Sterilization of concentrated gel solutions should use high-temperature instantaneous sterilization equipment at 140°C for 4 seconds to control microbial content to meet national hygiene quality standards.
5. Freezing, drying, and crushing of concentrated gel solutions should occur in a closed system, with purified air used for drying.
6. Containers storing semi-finished gel powder must remain clean, disinfected with ultraviolet light before use. Semi-finished products should be sampled and tested in determined batches, with only those meeting hygiene standards used for final product mixing.
7. Mixing and packaging operations should be equipped with UV disinfection, and packaged products should be sent out through pass-through windows.
Article 26 All original records of the production process (including inspection results of critical factors in the process specifications), original data of inspection for each batch of products, and inspection reports should be properly preserved. Records should be kept for at least six months longer than the product's shelf life for verification purposes.
Article 27 Packaging containers and materials should be intact and meet the corresponding national hygiene standards for food containers and packaging materials.
Article 28 Product labels and instructions should comply with the "Food Hygiene Law of the People's Republic of China" and the "Hygiene Management Measures for Food Additives".
Article 29 Equipment, tools, pipelines, containers, and premises should be cleaned and disinfected before and after use, with records maintained. Maintenance and inspection of equipment should not contaminate products.
Article 30 Harmful gases, strong acids, strong alkalis, and other chemical corrosives, dust, noise, and sewage produced during the production process should be treated to meet the corresponding national emission standards.